Trial · NCT07914231
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction of 75% in PASI score relative to baseline (PASI75) at Week 12 | From enrollment to the end of treatment at 12 weeks | The Psoriasis Area and Severity Index (PASI) combines assessments of the extent of body-surface involvement in 4 anatomical regions (head and neck, upper limbs, trunk, lower limbs) and the severity of erythema, induration, and desquamation in each region, yielding an overall score of 0 to 72. A frequency table of participants with a reduction of 75% in PASI score relative to baseline (PASI75) at Week 12 per intervention arm. |
| Secondary | Treatment-emergent adverse events (TEAEs), treatment emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation | From enrollment to the end of follow-up at 16 weeks | Number and percentage of participants with events per intervention arm, and total number of events by intervention arm. |
| Secondary | PASI score and percentage change from baseline in PASI score at Week 12 | From enrollment to the end of treatment at 12 weeks | The Psoriasis Area and Severity Index (PASI) combines assessments of the extent of body-surface involvement in 4 anatomical regions (head and neck, upper limbs, trunk, lower limbs) and the severity of erythema, induration, and desquamation in each region, yielding an overall score of 0 to 72. Descriptive statistics at Week 12 per intervention arm of the actual values and the percent changes from baseline. |
| Secondary | Reduction of 50/90/100% in PASI score relative to baseline at Week 12 | From enrollment till end of treatment at 12 weeks | The Psoriasis Area and Severity Index (PASI) combines assessments of the extent of body-surface involvement in 4 anatomical regions (head and neck, upper limbs, trunk, lower limbs) and the severity of erythema, induration, and desquamation in each region, yielding an overall score of 0 to 72. A frequency table of participants with a reduction of 50/90/100% in PASI score relative to baseline (PASI50/PASI90/PASI100) at Week 12 per intervention arm. |
| Secondary | PASI score ≤1 at Week 12 | From enrollment till end of treatment at 12 weeks | The Psoriasis Area and Severity Index (PASI) combines assessments of the extent of body-surface involvement in 4 anatomical regions (head and neck, upper limbs, trunk, lower limbs) and the severity of erythema, induration, and desquamation in each region, yielding an overall score of 0 to 72. A frequency table of participants with a PASI score ≤1 at Week 12 per intervention arm. |
| Secondary | Percentage change from baseline in affected BSA at Week 12 | From enrollment till end of treatment at 12 weeks | The percentage of surface area of the body (BSA) involved with plaque psoriasis. The handprint method for assessing BSA will be used, where the surface area of the participant's hand, including the palm and all 5 digits, is used as a guide to estimate 1% BSA. Descriptive statistics at Week 12 per intervention arm of percent changes from baseline. |
| Secondary | Change from baseline in sPGA score of plaque psoriasis at Week 12 | From enrollment till end of treatment at 12 weeks | A global assessment of psoriasis disease activity performed by the physician (sPGA). The sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity will be assessed by a physician for the 3 primary signs of psoriasis (induration, erythema, and scaling), scored as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). Descriptive statistics at Week 12 per intervention arm of changes from baseline. |
| Secondary | Change from baseline in PtGA score of plaque psoriasis at Week 12 | From enrollment till end of treatment at 12 weeks | A global assessment of psoriasis disease activity performed by the participant (PtGA). The PtGA of psoriasis is a single-item, patient-completed assessment that is used to evaluate the overall extent of psoriasis-related cutaneous disease at a particular point in time using an 11-point Numerical Rating Scale (NRS), answering the question "On a scale from 0 to 10, with 0 being 'not at all' and 10 being 'very severe', how would you rate the severity of your PsO at this moment? Descriptive statistics at Week 12 per intervention arm of changes from baseline. |
| Secondary | sPGA score of 0 (clear) or 1 (minimal disease) at Week 12 | From enrollment till end of treatment at 12 weeks | A global assessment of psoriasis disease activity performed by the physician (sPGA). The sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity will be assessed by a physician for the 3 primary signs of psoriasis (induration, erythema, and scaling), scored as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). A frequency table of participants with a sPGA score of 0 or 1 at Week 12 per intervention arm. |
| Secondary | sPGA score of 0 (clear) or 1 (minimal disease) and improvement of ≥2 points relative to baseline at Week 12 | From enrollment till end of treatment at 12 weeks | A global assessment of psoriasis disease activity performed by the physician (sPGA). The sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity will be assessed by a physician for the 3 primary signs of psoriasis (induration, erythema, and scaling), scored as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). A frequency table of participants with a sPGA score of 0 or 1 and an improvement of ≥2 points relative to baseline at Week 12 per intervention arm. |
| Secondary | sPGA score of 0 at Week 12 | From enrollment till end of treatment at 12 weeks | A global assessment of psoriasis disease activity performed by the physician (sPGA). The sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity will be assessed by a physician for the 3 primary signs of psoriasis (induration, erythema, and scaling), scored as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). A frequency table of participants with a sPGA score of 0 at Week 12 per intervention arm. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07914231/registered